U.S. patent application number 13/670745 was filed with the patent office on 2013-05-09 for surgical access device and surgical access system.
This patent application is currently assigned to AESCULAP AG. The applicant listed for this patent is Aesculap AG. Invention is credited to Theodor Lutze, Tom Schweitzer.
Application Number | 20130116510 13/670745 |
Document ID | / |
Family ID | 48128751 |
Filed Date | 2013-05-09 |
United States Patent
Application |
20130116510 |
Kind Code |
A1 |
Lutze; Theodor ; et
al. |
May 9, 2013 |
SURGICAL ACCESS DEVICE AND SURGICAL ACCESS SYSTEM
Abstract
In a first aspect of the invention, a surgical access device for
inserting surgical instruments into the body of a patient comprises
a sleeve section defining a longitudinal axis and also a working
channel. A ratio between a length and an internal diameter of the
sleeve section lies in a range of approximately 4:1 to
approximately 14. In a second aspect of the invention, a surgical
access system comprises a surgical access device for introducing
surgical instruments into the body of a patient which comprises a
sleeve section defining a longitudinal axis, and also comprising an
insertion instrument for inserting the access device into an
abdominal wall of the patient in particular. A ratio between a
length and an internal diameter of the sleeve section lies in a
range of approximately 4:1 to approximately 14:1.
Inventors: |
Lutze; Theodor; (Balgheim,
DE) ; Schweitzer; Tom; (Tuttlingen, DE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Aesculap AG; |
Tuttlingen |
|
DE |
|
|
Assignee: |
AESCULAP AG
Tuttlingen
DE
|
Family ID: |
48128751 |
Appl. No.: |
13/670745 |
Filed: |
November 7, 2012 |
Current U.S.
Class: |
600/208 |
Current CPC
Class: |
A61B 17/3423 20130101;
A61B 17/3462 20130101; A61B 2017/3484 20130101; A61B 1/32 20130101;
A61B 2017/3441 20130101; A61B 17/3421 20130101 |
Class at
Publication: |
600/208 |
International
Class: |
A61B 1/32 20060101
A61B001/32 |
Foreign Application Data
Date |
Code |
Application Number |
Nov 8, 2011 |
DE |
10 2011 055 129 |
Claims
1. A surgical access device for inserting surgical instruments into
the body of a patient, comprising a sleeve section defining a
longitudinal axis and also a working channel, wherein a ratio
between a length and an internal diameter of the sleeve section
lies in a range of approximately 4:1 to approximately 14:1.
2. A surgical access device in accordance with claim 1, wherein the
ratio between the length and the internal diameter of the sleeve
section lies in a range of approximately 7:1 to approximately
11:1.
3. A surgical access device in accordance with claim 1, wherein a
length of the sleeve section lies in a range of approximately 15 mm
to approximately 50 mm, preferably within a range of approximately
25 mm to approximately 40 mm.
4. A surgical access device in accordance with claim 1, wherein a
first annular flange directed away from the longitudinal axis in a
radial direction is formed at a proximal end of the sleeve
section.
5. A surgical access device in accordance with claim 4, wherein a
ratio of the outer diameter of the first annular flange and the
outer diameter of the sleeve section lies in a range of
approximately 1.5:1 to approximately 3:1, preferably in a range of
approximately 2:1 to approximately 2.5:1.
6. A surgical access device in accordance with claim 1, wherein a
second annular flange directed away from the longitudinal axis in a
radial direction is formed at a distal end of the sleeve
section.
7. A surgical access device in accordance with claim 1, wherein a
distal end of the sleeve section widens out or opens outwardly away
from the longitudinal axis.
8. A surgical access device in accordance with claim 1, wherein the
sleeve section is formed from a resiliently deformable
material.
9. A surgical access device in accordance with claim 1, wherein a
sealing element projecting from an inner wall of the sleeve section
in the direction of the longitudinal axis is arranged or formed in
the region of a proximal end of the sleeve section.
10. A surgical access device in accordance with claim 9, wherein
the sealing element is in the form of an annular flange, a sealing
bead or a sealing lip.
11. A surgical access device in accordance with claim 1, wherein a
valve element is arranged or formed in the working channel.
12. A surgical access device in accordance with claim 11, wherein
the valve element is in the form of a duckbill or a cross slot
valve.
13. A surgical access device in accordance with claim 12, wherein
the valve element is arranged or formed on the sleeve section
approximately centrally between its proximal and distal end (20,
42).
14. A surgical access device in accordance with claim 1,
characterized by a restraining device for preventing a movement of
an access device in the proximal direction particularly one that
has been inserted into an abdominal wall of a patient.
15. A surgical access device in accordance with claim 14, wherein
the restraining device comprises at least one restraining member
which comprises a restraining surface facing in the proximal
direction.
16. A surgical access device in accordance with claim 15, wherein
the at least one restraining member is held on the sleeve section
in moveable manner and is moveable from an introduction position
into a restraining position.
17. A surgical access device in accordance with claim 15, wherein
the distal end of the at least one restraining member is arranged
or formed on the sleeve section and wherein a free proximal end of
the at least one restraining member is directed somewhat away from
the longitudinal axis in the proximal direction.
18. A surgical access device in accordance with claim 1, wherein at
least the sleeve section is made of an elastomer, preferably from a
thermoplastic elastomer or an elastomer foam.
19. A surgical access device in accordance with claim 18, wherein
the sleeve section formed from the elastomer itself forms the valve
element.
20. A surgical access device in accordance with claim 18, wherein
the entire access device is made of an elastomer, preferably from a
thermoplastic elastomer or an elastomer foam.
21. A surgical access device in accordance with claim 1, wherein it
is formed in one piece manner.
22. A surgical access system comprising a surgical access device
for introducing surgical instruments into the body of a patient
which comprises a sleeve section defining a longitudinal axis, and
also comprising an insertion instrument for inserting the access
device into an abdominal wall of the patient in particular, wherein
a ratio between a length and an internal diameter of the sleeve
section lies in a range of approximately 4:1 to approximately
14:1.
23. A surgical access system in accordance with claim 22, wherein a
length of the sleeve section lies in a range of approximately 15 mm
to approximately 50 mm, preferably within a range of approximately
25 mm to approximately 40 mm.
24. A surgical access system in accordance with claim 22, wherein
the insertion instrument comprises a holding section for at least
one surgical access device.
25. A surgical access system in accordance with claim 24, wherein a
stop acting in the proximal direction is arranged or formed on the
distal side of the holding section.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of German application
number 10 2011 055 129.8 filed Nov. 8, 2011, which is incorporated
herein by reference in its entirety and for all purposes.
FIELD OF THE INVENTION
[0002] The present invention relates to a surgical access device
for introducing surgical instruments into the body of a patient,
comprising a sleeve section defining a longitudinal axis and also a
working channel.
[0003] Furthermore, the present invention relates to a surgical
access system having a surgical access device for introducing
surgical instruments into the body of a patient which comprises a
sleeve section defining a longitudinal axis and also a working
channel, and an insertion instrument for inserting the access
device particularly into an abdominal wall of the patient.
BACKGROUND OF THE INVENTION
[0004] Usually trocars are used for creating access to the interior
of the body of a patient for minimally invasive surgical
procedures. Trocars are used in particular in the field of
laparoscopy and basically serve the purpose of creating a gas-tight
access to the field of the operation. Trocars usually comprise a
trocar sleeve and an obturator with which the trocar sleeve is
closed when being introduced through the abdominal wall of the
patient into the abdominal cavity for example.
[0005] A disadvantage of conventional trocars is that their trocar
sleeves additionally comprise a trocar head in which there are
arranged or formed a sealing unit and a valve, preferably with a
standardized Luer-Lok connector, in order to fill the abdominal
cavity of the patient with an inert gas. The trocar heads then
usually stick out from the abdominal wall and, in the most
unfavourable case, can hook themselves onto cables and hoses which
are needed for the surgical procedure.
[0006] However, due to the space required by the trocar heads, it
is not possible to place the trocars very close to one another.
Consequently, two to three very closely adjacent points of access
to the patient's body cannot be opened with trocars. At all events,
this is possible with a so-called "single-port" technique which,
for example, provides two to three very closely adjacent points of
access in the region of the navel in a single device. Moreover,
re-usable trocars in particular have a high dead weight and may be
top-heavy so that there is an increased risk that they could tip
over. Changing the instrument is thus made more difficult and an
additional hand is needed for holding the trocar sleeve.
[0007] The aforesaid problems are circumvented particularly in the
field of arthroscopy by partly dispensing completely with trocars,
and endoscopic instruments are introduced directly through the
tissue. Here however, the danger exists that with each change of
instrument the instruments hook themselves into the layers of
tissue and renewed introduction thereof is made more difficult.
[0008] An object of the present invention is to improve a surgical
access device and also a surgical access system of the type
initially described in such a way that a simple and safe access
into the body of a patient is made possible.
SUMMARY OF THE INVENTION
[0009] In a first aspect of the invention, a surgical access device
for inserting surgical instruments into the body of a patient
comprises a sleeve section defining a longitudinal axis and also a
working channel. A ratio between a length and an internal diameter
of the sleeve section lies in a range of approximately 4:1 to
approximately 14.
[0010] In a second aspect of the invention, a surgical access
system comprises a surgical access device for introducing surgical
instruments into the body of a patient which comprises a sleeve
section defining a longitudinal axis, and also comprising an
insertion instrument for inserting the access device into an
abdominal wall of the patient in particular. A ratio between a
length and an internal diameter of the sleeve section lies in a
range of approximately 4:1 to approximately 14:1.
BRIEF DESCRIPTION OF THE DRAWING FIGURES
[0011] The foregoing summary and the following description may be
better understood in conjunction with the drawing figures, of
which:
[0012] FIG. 1: shows a partly sectional perspective view of a first
exemplary embodiment of a surgical access device;
[0013] FIG. 2: a schematic longitudinal sectional view of a second
exemplary embodiment of a surgical access device;
[0014] FIG. 3: a schematic longitudinal sectional view of a third
exemplary embodiment of a surgical access device;
[0015] FIG. 4: a schematic illustration of a first exemplary
embodiment of an insertion instrument when inserting the access
device illustrated in FIG. 1;
[0016] FIG. 5: a schematic longitudinal sectional view of a second
exemplary embodiment of an insertion instrument when inserting the
access device illustrated schematically in FIG. 1;
[0017] FIG. 6: a schematic illustration similar to FIG. 5 wherein
there are two access devices that are held one behind the other on
the holding section of the insertion instrument;
[0018] FIG. 7: a schematic longitudinal sectional view of a fourth
exemplary embodiment of a surgical access device;
[0019] FIG. 8A: a schematic longitudinal sectional view of a fifth
exemplary embodiment of a surgical access device in the
introduction position;
[0020] FIG. 8B: a side view of the surgical access device
illustrated in FIG. 8A;
[0021] FIG. 8C: a view similar to FIG. 8A, wherein the access
device has adopted a restraining position; and
[0022] FIG. 9: a schematic sectional view of a sixth exemplary
embodiment of a surgical access device.
DETAILED DESCRIPTION OF THE INVENTION
[0023] Although the invention is illustrated and described herein
with reference to specific embodiments, the invention is not
intended to be limited to the details shown. Rather, various
modifications may be made in the details within the scope and range
of equivalents of the claims and without departing from the
invention.
[0024] The present invention relates to a surgical access device
for inserting surgical instruments into the body of a patient,
comprising a sleeve section defining a longitudinal axis and also a
working channel, wherein a ratio between a length and an internal
diameter of the sleeve section lies in a range of approximately 4:1
to approximately 14:1.
[0025] The provision of surgical access devices having sleeve
sections which exhibit such a length to internal diameter
relationship makes it possible to create a particularly small and
compact point of access into the interior of the body of a patient.
In particular, for ever decreasing instrument shafts having
diameters between 3 and 5 mm, they make possible a sufficiently
short overall length so that neither are there disturbing trocar
heads located outside the body nor is there a risk of tipping of
the access device. The proposed surgical access device can thus be
formed, in particular, without trocars. Due to the resultant
overall very small and compact construction of the access device,
the points of access to the patient's body are also very small and
non-traumatic. For example, they can be set very close to one
another in the region of the navel of a patient and hence also form
an alternative to the initially mentioned "single-port" technique.
In any case, two or more placed access devices have the advantage
that any possible deflections thereof with instruments will be less
mutually interactive than is the case for trocars incorporating two
or more working channels, so-called "single-port" trocars. Due to
their small size, the proposed surgical access devices can be used
both in the abdominal wall for laparoscopic procedures as well as
in the knee for arthroscopic procedures. In particular, access
devices can also be supplied in a set of different lengths so that,
after firstly determining a thickness such as that of the abdominal
wall for example, an operating surgeon can select the optimally
matching access device which will protrude only minimally on the
inside and the outside of the abdominal wall.
[0026] It is particularly expedient if the ratio between the length
and the internal diameter of the sleeve section lies in a range of
approximately 7:1 to approximately 11:1. Such a length to internal
diameter relationship of the sleeve section, makes it possible for
the surgical access device to be employed universally particularly
for shaft diameters of 3 mm to 5 mm, and indeed, without the access
device undesirably sticking out a long way on the inside and the
outside of the abdominal wall or the knee of a patient. In other
words, with the aid of the trocar-less surgical access device, it
is possible to create a point of access which extends substantially
just through the body tissue of the patient and is suitable for the
introduction of surgical instruments. In this way in particular,
the surgical access device forms a kind of plug with a passage
channel which is characterised by an optimised length to diameter
relationship.
[0027] Advantageously, a length of the sleeve section lies in a
range of approximately 15 mm to approximately 50 mm. Preferably, a
length of the sleeve section lies in a range of approximately 25 mm
to approximately 40 mm. Consequently, particularly in combination
with an internal diameter of the sleeve section preferably in a
range of approximately 3 mm to approximately 5 mm, this results in
a very small port which is sufficient to penetrate the abdominal
wall in particular and to protect it from injury when introducing
instruments. The application of two or more access devices in
direct proximity is easily possible.
[0028] It is expedient if a first annular flange directed away from
the longitudinal axis in a radial direction is formed at a proximal
end of the sleeve section. This can, in particular, prevent the
access device from slipping into the interior of the body of the
patient through an incision in the abdominal wall or on the knee.
It can be advantageous in particular, if the annular flange is
opened or formed in funnel-like manner pointing in the proximal
direction. The introduction of instruments into the guidance or
working channel defined by the sleeve section is thereby
facilitated. In particular, the annular flange may comprise a
conical sliding surface which tapers in the distal direction.
[0029] It is advantageous, if the ratio of the outer diameter of
the annular flange to the outer diameter of the sleeve section lies
in a range of approximately 1.5:1 to approximately 3:1.
Expediently, the ratio of the outer diameter of the annular flange
to the outer diameter of the sleeve section lies in a range of
approximately 2:1 to approximately 2.5:1. These ratios make it
possible, in particular, to ensure secure placement of the first
annular flange on the outside of the skin of the patient in order
to prevent the access device slipping through into the interior of
the body of the patient.
[0030] It is advantageous if a second annular flange directed away
from the longitudinal axis in a radial direction is formed at a
distal end of the sleeve section. Such a second annular flange can,
in particular, also prevent the access device itself from being
pulled out of an incision in the body of the patient
unintentionally when pulling an instrument out of the access
device.
[0031] In order not to make the introduction of the access device
through an incision in an abdominal wall of the patient for
example, and the withdrawal thereof after the procedure has been
completed unnecessarily more difficult, it is expedient if an outer
diameter of the first annular flange is greater than an outer
diameter of the second annular flange.
[0032] Furthermore, it can be advantageous if a distal end of the
sleeve section widens out or opens outwardly away from the
longitudinal axis. Thus, in particular, projecting parts of the
instrument can be fed back properly into the working channel after
the withdrawal of an instrument. Furthermore, a force for retaining
the access device on the patient's body can thus also be increased.
Moreover, haemorrhages through the second annular flange or of the
opening or widening distal end of the sleeve section can also be
stopped or minimized. At the same time, a drip-edge for preventing
contamination especially of an endoscope lens of an endoscope
particularly in the case of haemorrhages can be formed by
appropriate shaping of the distal end.
[0033] It is particularly expedient if the sleeve section is formed
from a resiliently deformable material. Such an arrangement makes
it possible, in particular, for the sleeve section itself to be
used as a sealing element or valve because it can be squeezed
together due to the tissue-tension of the tissue surrounding the
sleeve section so that the working channel is sealed automatically.
Furthermore, the introduction and extraction of instruments and
endoscopic optics through the access device can be facilitated by
forming the sleeve section from a resiliently deformable
material.
[0034] It is expedient if a sealing element which projects from an
inner wall of the sleeve section in the direction of the
longitudinal axis is arranged or formed in the region of a proximal
end of the sleeve section. Independently of whether the sleeve
section is made of a resilient or inelastic material, the sealing
element can seal the access device relative to an instrument shaft
which can, in particular, have a somewhat smaller outer diameter
than the internal diameter of the working channel. The sealing
element can be formed on the sleeve section or formed in one piece
manner therewith.
[0035] It is advantageous if the sealing element is arranged or
formed at the level of a distal end of the first annular flange.
For example, it can be formed or moulded on the sleeve section
together with the first annular flange. Arranging or forming the
sealing element on the sleeve section as far as possible towards
the proximal end has the advantage that an instrument shaft is
sealed in the desired manner practically immediately after being
introduced into the access device. Thus in particular, a loss of
gas through the access device can thereby be minimized.
[0036] The sealing element can be formed and produced in a
particularly simply manner if it is in the form of an annular
flange, a sealing bead or a sealing lip.
[0037] In order to also enable the access device to be used for
laparoscopic procedures wherein the abdominal wall is raised by
flooding the abdominal cavity with gas, it is expedient if a valve
element is arranged or formed in the working channel. In
particular, the valve element then prevents gas from escaping from
the abdominal cavity when no instrument has been introduced into
the working channel of the access device.
[0038] The construction and also the production of the valve
element are particularly simple, if it is in the form of a duckbill
or a cross slot valve. In particular, the valve element can be
formed in one piece manner with the sleeve section or formed
thereon by means of a moulding process for example.
[0039] It is particularly simple for the production of the access
device, if the valve element is arranged or formed on the sleeve
section approximately centrally between the proximal and distal
ends thereof.
[0040] Furthermore it can be advantageous if the valve element is
arranged or formed on the distal side of the sealing element.
Preferably, it borders directly thereon. This makes it possible to
introduce an instrument into the working channel which is sealed by
the valve element, whereby the valve element keeps the working
channel closed until such time as the sealing element can ensure a
seal to the instrument shaft.
[0041] In accordance with a further preferred embodiment of the
invention, provision may be made for the access device to comprise
a restraining device for preventing a movement of an access device
in the proximal direction particularly one that has been inserted
into an abdominal wall of a patient. Self evidently, the
restraining device can also prevent or make more difficult a
movement out of the body of a patient at some other position. The
effect of the restraining device is desirable and advantageous
particularly when an instrument is being withdrawn from the working
channel of the access device.
[0042] The restraining device can be formed in a particularly
simple manner if it comprises at least one restraining member which
comprises a restraining surface facing in the proximal direction.
In particular, the restraining surface can extend transversely
relative to a longitudinal axis of the working channel so that,
upon the introduction of the sleeve section into the body tissue of
the patient, the at least one restraining member will hook itself
into the surrounding body tissue by a movement in the proximal
direction and can thereby prevent unintentional withdrawal of the
access device or at least make it significantly more difficult.
[0043] It is particularly advantageous if two, three or more
restraining members are provided. In particular, the restraining
members can all be formed identically or may differ in type, size
and construction.
[0044] In particular, a particularly simple construction of the
access device can be achieved in that the at least one restraining
member is in the form of a projection from the sleeve section which
is directed away from the longitudinal axis in a radial
direction.
[0045] The access device can be introduced into the body of the
patient in the distal direction in a particularly simple manner if
the projection comprises a sliding surface which is directed away
from the longitudinal axis and is inclined in the distal
direction.
[0046] The at least one restraining member can exercise its
restraining function to particularly good effect, if the projection
extends at least partly over the periphery of the sleeve section in
the peripheral direction. Preferably, the projection extends over
the entire periphery of the sleeve section. In other words, the
projection can also be formed so as to surround the sleeve section
in ring-like manner.
[0047] It is advantageous if the at least one restraining member is
held on the sleeve section in moveable manner and is moveable from
an introduction position into a restraining position. Due to this
arrangement, it is possible to introduce the access device into the
body tissue in a simple manner when the at least one restraining
member adopts the introduction position, and to hold it on the body
of the patient in a defined and secure manner when the at least one
restraining member adopts the restraining position.
[0048] It is expedient if the at least one restraining member is
mounted on the sleeve section such as to be pivotal about a pivotal
axis. Such an arrangement can be formed in a simple manner and
prescribe a defined movement of the at least one restraining
member.
[0049] It is advantageous if the pivotal axis extends transversely
or substantially transversely with respect to the longitudinal
axis. This permits the at least one restraining member to pivot in
such a way that it projects laterally from the sleeve section in
the restraining position for example.
[0050] In order to simplify the arrangement particularly in the
case of very small access devices, it is advantageous if the at
least one restraining member is mounted on the sleeve section in
moveable manner by means of a pivotal joint or a hinge joint and in
particular, the hinge joint can be in the form of a film hinge so
that the joint can be formed in one piece manner with the sleeve
section.
[0051] In order for the restraining function exercised by the
restraining device to be as uniform as possible, it is expedient
for two restraining members to be arranged or formed diametrically
opposite each other taken with respect to the longitudinal
axis.
[0052] The construction of the access device can be simplified
further if the at least one restraining member is formed such as to
be tab-shaped. In particular, tab-shaped can mean that the support
element is in the form of a flat elongated cuboid.
[0053] The access device can be produced in a simple manner and be
anchored in the body tissue like a dowel, if the distal end of the
at least one restraining member is arranged or formed on the sleeve
section and if a free proximal end of the at least one restraining
member is directed somewhat away from the longitudinal axis in the
proximal direction. The at least one restraining member can thus be
in the form of a sort of barb.
[0054] Furthermore, it can be advantageous if the at least one
restraining member forms a section of the wall of the sleeve. In
particular, it can thus form a part of the sleeve-wall of the
sleeve section in the introduction position.
[0055] It is expedient if the at least one restraining member forms
a part of a sleeve wall of the sleeve section in the introduction
position and if it protrudes or is deflected at least partly away
from the longitudinal axis in a radial direction in the restraining
position. In particular, the access device can then be transferred
from the introduction position into the restraining position in a
simple and certain manner, by deflecting or pivoting the at least
one restraining section for example.
[0056] In order to enable particularly secure hooking or fixing of
the access device in the body tissue of the patient to be achieved,
it is expedient if the at least one restraining member is arranged
or formed in the region of the distal half of the sleeve section.
In this way, when withdrawing the access device in the proximal
direction, more body tissue has to be negotiated than in the case
of an arrangement of the at least one restraining member in the
region of a proximal end of the sleeve section.
[0057] In accordance with a preferred embodiment of the invention,
provision may be made for the restraining surface to define a plane
which includes an angle of between approximately 75.degree. and
105.degree. with the longitudinal axis. Preferably, the angle
amounts to approximately 90.degree.. If the included angle is an
acute angle which points in the proximal direction, then a barbed
construction of the restraining device can be formed in a simple
manner.
[0058] Furthermore, it can be expedient if the access device
comprises at least one restraining member in the form of an
external thread which is arranged or formed on the sleeve section.
The access device can then be quasi screwed or rotated into the
body tissue for example. The flanks of the screw thread then
prevent a movement of the sleeve section in the proximal direction
in a simple manner so that corresponding forces have to be applied
for removing it during the withdrawal process.
[0059] It is advantageous if at least the sleeve section is made of
an elastomer, preferably from a thermoplastic elastomer or an
elastomer foam. Thus for example, as already described hereinabove,
the sleeve section can also serve as a sealing element or valve
element for the access device itself if, in particular, it is
formed to be so resilient that it can be squeezed together by the
body tissue surrounding it in order to close the working channel.
Furthermore for example, the sleeve section can be made of an
elastomer, optionally provided annular flanges at the proximal
and/or distal end of the sleeve section can be made of a
substantially inelastic synthetic material. In dependence on the
function of the corresponding parts or elements of the access
device, they can be formed as appropriate from a resilient or from
a substantially inelastic material. The production of the access
device from one or more synthetic materials makes for a simple and
economical production process, by injection moulding for
example.
[0060] It is expedient if the sleeve section formed from the
elastomer itself forms the valve element. A valve element which is
complicated to arrange and form in the working channel is then no
longer necessary in this case.
[0061] The production of the access device can be simplified
further, if it is made entirely of an elastomer. Preferably, it is
made of a thermoplastic elastomer or an elastomer foam.
[0062] In order to simplify the introduction of the access device
into the body of the patient and/or the introduction of an
instrument through the access device, it is expedient if an inner
surface and/or an outer surface of the access device is provided
with a friction-reducing coating.
[0063] Furthermore, the stability of the access device can be
increased and also the production thereof can be simplified if it
is formed in one piece manner.
[0064] Furthermore, the present invention relates to a surgical
access system comprising a surgical access device for introducing
surgical instruments into the body of a patient which comprises a
sleeve section defining a longitudinal axis, and also comprising an
insertion instrument for inserting the access device into an
abdominal wall of the patient in particular, wherein a ratio
between a length and an internal diameter of the sleeve section
lies in a range of approximately 4:1 to approximately 14:1. As has
already been explained in detail hereinabove, such an access system
incorporating the improved surgical access device makes it possible
to create one or more access points into the body of a patient in a
simple manner. In particular, one can thereby dispense with large
trocars having trocar heads and the initially described
disadvantages.
[0065] It is advantageous if the surgical access system comprises
one of the access devices described above. The surgical access
system then likewise exhibits the advantages described above in
connection with preferred embodiments of the surgical access
devices.
[0066] In order to simplify the insertion of the surgical access
device, it is advantageous if the insertion instrument comprises a
holding section for at least one surgical access device.
Preferably, the holding section can be formed in such a manner that
two, three or even more access devices can be held thereon
simultaneously. This permits one, two or yet more access points or
ports into the interior of the body of the patient to be created
successively using just one insertion instrument.
[0067] In order to prevent a surgical access device that is held on
the holding section from being able to slip down off the holding
section in the distal direction when this is not desired, it is
expedient if a stop acting in the proximal direction is arranged or
formed at the distal side of the holding section.
[0068] Such a stop can be formed in a simple manner if it has a
larger outer diameter than the holding section. The stop can, in
particular, be in the form of an annular projection or flange
which, however, preferably does not have sharp edges. This enables
the sleeve section of the access device to be pushed quite
deliberately over the stop whereby the sleeve section can
preferably be temporarily expanded for this purpose.
[0069] It is advantageous for the holding section to be of a length
which corresponds to at least twice the length of the sleeve
section of a surgical access device. In this way, at least two or
even more surgical access devices can be held on the holding
section in dependence on how long the holding section actually
is.
[0070] In order to place the at least one access device which is
held on the holding section in the body tissue of the patient in
the desired manner, it is advantageous if a feed element having a
stop surface facing in the distal direction is arranged or formed
on the proximal side of the holding section. Such a stop prevents
the sleeve section that is held on the holding section from being
arbitrarily displaced in the proximal direction duannular the
introduction thereof. The holding section with such a stop makes it
possible to introduce and place the access device in the body of
the patient in a safe and purposeful manner.
[0071] It is advantageous if the feed element is held immovably on
the holding section. In particular in such a case, one can
completely dispense with a stop adjoining the retaining section at
the distal side thereof. For example, the sleeve section can be
securely held on the holding section in a simple manner in that the
internal diameter of the sleeve section is a little smaller than
the outer diameter of the holding section. In particular, in
combination with a restraining device, it is practically impossible
to unintentionally pull a sleeve section, which has been placed by
the insertion instrument, out of the body tissue together with the
insertion instrument when the insertion instrument is being
withdrawn in the proximal direction.
[0072] Alternatively, it can also be expedient if the feed element
is formed such as to be moveable relative to the holding section in
the distal and the proximal direction. In particular, one or more
access devices can be successively pushed down off the holding
section in the distal direction in this way.
[0073] The insertion instrument can be formed in a simple manner if
the feed element is in the form of a sleeve surrounding the holding
section. Consequently, the distal end of the sleeve can form a stop
surface acting in the distal direction upon which the proximal end
of the sleeve section can be supported duannular insertion into the
body of the patient.
[0074] The handling of the insertion instrument can be improved in
a simple manner if a proximal end thereof is in the form of a
handle element or carries a handle element.
[0075] A surgical access device 10 designated as a whole by the
reference symbol 10 is illustrated schematically in FIG. 1. It
forms a part of a surgical access system designated as a whole by
the reference symbol 12 which, furthermore, comprises an insertion
instrument 14.
[0076] The access device 10, which may also be referred to as a
"mini-port", comprises a hollow cylindrical sleeve section 16 which
defines a working channel 18 in the interior thereof. A proximal
end 20 of the sleeve section 16 is provided with a first annular
flange 22 which extends away from a longitudinal axis 24 defined by
the sleeve section 16 in a radial direction. The ratio of the outer
diameter 26 of the first annular flange 22 to the outer diameter 28
of the sleeve section 16 preferably lies in a range of
approximately 2:1 to approximately 2.5:1.
[0077] The working channel 18 widens out conically in the proximal
direction in the region of the first annular flange 22 thereby
forming an inclined, funnel-like annular surface 30, the
surface-normal of which is inclined to the longitudinal axis 24 in
the proximal direction. In the transition region between the
annular surface 30 and a hollow cylindrical inner surface 32 of the
working channel 18, there is formed an annular, at least somewhat
resilient sealing element 34 in the form of an annular flange 36.
Alternatively, the sealing element 34 can also be in the form of a
sealing bead or a sealing lip. Consequently, the internal diameter
38 of the working channel 18 is somewhat reduced in the region of
the sealing element 34.
[0078] The first annular flange 22 has an annular surface 40 which
extends substantially transversely with respect to the longitudinal
axis 24 and faces in the distal direction and which also defines a
stop surface for body tissue. On the distal side thereof, the
internal diameter of the sleeve section 16 widens out conically
towards the distal end 42 thereof whereby the thus formed annular
surface 44 is inclined to the longitudinal axis 24 in the distal
direction. An opening angle defined by the annular surface 44 is
somewhat less than half as large as an opening angle defined by the
annular surface 30. The end 42 is defined by a second annular
flange 46, the outer diameter 48 of which is significantly smaller
than the outer diameter 26.
[0079] Both of the annular flanges 26 and 46 are completely rounded
and have no sharp edges. The annular surface 30 of the first
annular flange 22 forms a bell mouth 50 which serves as a means for
assisting the introduction of surgical instruments into the working
channel 18 and therethrough into the body of a patient.
[0080] The overall length 52 of the sleeve section 16 between the
ends 20 and 42 has a characteristic relationship to the internal
diameter 38 of the sleeve section. In the exemplary embodiment of
an access device 10 illustrated schematically in FIG. 1, it lies
within a range of approximately 5:1 to approximately 7:1. This
relationship could however lie within a range of approximately 4:1
to approximately 8:1. In order to let the size of the access device
10 become somewhat clearer, values in a range of approximately 15
mm to approximately 50 mm can be attributed to the overall length
52. For a large number of patients, it might be sufficient to
provide for the access device 10 to have an overall length 52 of
approximately 25 mm to approximately 40 mm. As illustrated
schematically in FIG. 4, this makes it possible for the access
device 10 to be inserted into a small incision 54 in an abdominal
wall 56 of a patient by means of the insertion instrument 14 so
that the annular surface 40 can abut or, better expressed, come
into abutment on an outer surface 58 of the abdominal wall 56 in
order to prevent the access device 10 from being introduced any
further into the body of the patient. In a similar way, the second
annular flange 46 serves to prevent the access device 10 from being
pulled out of the incision 54 inadvertently.
[0081] A second exemplary embodiment of a surgical access device is
schematically illustrated in FIG. 2 and is designated as a whole by
the reference symbol 70 therein. The basic construction thereof
corresponds to that of the access device 10 and differs therefrom
only in that it comprises a valve element 72 which is arranged in
the working channel 18. The valve element 72 comprises a short
sleeve section 74 which is arranged approximately centrally in the
working channel 18 between the ends 20 and 42 in such a manner that
the sleeve section 74 forms a part of the wall 60 and an inner wall
surface of the sleeve section 74 forms a part of an inner wall
surface of the sleeve section 16. Two valve flaps 78 that are
inclined at an angle to the longitudinal axis 24 and point in the
distal direction project from an annular end face 76 of the sleeve
section 74 facing in the distal direction, the free ends 80 of said
valve flaps abutting each other and closing the working channel 18
in gas-tight manner. The valve element 72 is thus in the form of a
duckbill valve 82 but could also be in the form of a cross slot
valve or some other similar type of valve in order to close the
working channel 18 in gas-tight manner. Moreover, the valve element
72 could also be arranged further towards the proximal end such as
directly adjacent the sealing element 34 for example.
[0082] Other than is the case for the access device 70 which is
schematically illustrated in FIG. 2, one can dispense with an
additional valve element 72 in the case of the access device 10 if,
for example, a wall 60 bounding the working channel 18 is made from
a resilient material such as an elastomer for example, and in
particular a thermoplastic elastomer or an elastomer foam, so that
a tissue-tension of the tissue of the abdominal wall 16 surrounding
the sleeve section 16 is of itself sufficient to squeeze the sleeve
section 16 together in such a way that the working channel 18 is
closed as is illustrated schematically in FIG. 3. Due to this
special arrangement, the sleeve section comprising a resilient wall
60 itself forms the valve element 72. For the purposes of opening
the latter after the introduction of an instrument, the wall 60 is
pressed outwardly on all-sides as would similarly be the case too
for the duckbill valve 82 or any other type of valve element.
[0083] The insertion instrument 14, which is illustrated
schematically in FIGS. 4 to 6, serves for the insertion of the
access devices 10 and 70 and also further access devices which will
be described in more detail hereinafter. It comprises a handle
element 88 at the proximal end 86 with the aid of which an
operating surgeon can grasp, hold and guide the insertion
instrument 14. The insertion instrument 14 can, in particular, be
formed such that it is rotationally symmetrical about a
longitudinal axis 90 defined thereby.
[0084] On the distal side of the handle element 88, there extends a
shaft section 92 which can have a specific length in dependence on
the purpose for which the insertion instrument 14 is to be used.
The outer diameter of the end of the shaft section 92 widens out
and thus forms a conical feed element 94 which comprises a stop
surface 96 facing in the distal direction. Protruding from the stop
surface 96 there is a cylindrical holding section 98 having an
outer diameter 100 which corresponds approximately to the outer
diameter of the shaft section 92. The outer diameter 100 is smaller
than the internal diameter 38, but is somewhat larger than the
internal diameter defined by the sealing element 34. This makes it
possible for an access device 10 to be pushed onto the holding
section 98 by its proximal end 20. Due to the described ratios of
the diameters, the access device 10 is held on the holding section
98 by virtue of the frictional forces effective between the latter
and the sealing element 34.
[0085] Adjoining the holding section 98 at the distal end thereof,
there is a spreading body 102 which is formed from a cone 104 and a
tapered-pin 106. The surface areas of the cone 104 and the
tapered-pin 106 are connected to one another quasi directly and
define a maximum outer diameter 108 of the spreading body 102 which
is just a little smaller than the outer diameter 48 of the second
annular flange 46. Commencing from the holding section 98, there is
firstly formed the cone 104 which has an outer diameter that
increases up to the maximum outer diameter 108. Following the cone
104 on the distal side thereof, is the tapered-pin 106 which has a
rounded off peak 110 pointing in the distal direction. The
transition region between the cone 104 and the tapered-pin 106 is
also completely rounded. An outer wall surface 112 of the cone 104
serves as a contact surface or stop surface for the annular surface
44. The cone 104 of the spreading body 102 thus forms a stop 114
which acts in the proximal direction and prevents the access device
10 that has been pushed onto the holding section 98 from slipping
down off the holding section 98 in the distal direction.
[0086] For the purposes of inserting the access device 10, the
latter is pushed over the spreading body 102 onto the holding
section 98. This is easily possible if it is made of a resiliently
deformable material. The access device 10 is pushed onto the
holding section 98 until the first annular flange 22 rests against
the stop surface 96. After opening the abdominal wall 56, an
operating surgeon can then push the insertion instrument 14 with
the spreading body 102 forwardly into the incision 54 until the
annular surface 40 comes to rest on the outer surface 58 of the
abdominal wall 56. The access device 10 to be utilised is
preferably selected from an available set of access devices having
different overall lengths in such a way that, due to the selected
overall length 52, the second annular flange 46 protrudes out
somewhat from the incision 54 inside the patient.
[0087] When the access device 10 has been placed in the desired
way, the insertion instrument 14 can be pulled out of the working
channel 18 in the proximal direction. To this end, the access
device 10 is held at the first annular flange 22 and the insertion
instrument 14 is pulled out. This method of procedure is utilised
when the feed element 94 and the holding section 98 are arranged or
formed such that they are immoveable relative to each other.
[0088] A slightly modified insertion instrument 14' which comprises
a feed element 94' in the form of a sleeve 116 that is held in
displaceable manner on the holding section 98 is illustrated
schematically in FIGS. 5 and 6. This has a stop surface 96' facing
in the distal direction, from which projects the holding section 98
likewise oriented in the distal direction.
[0089] For the purposes of applying the access device 10, the
access device 10 is pushed forwardly by its proximal end 20 over
the spreading body 102 and onto the holding section 98 from the
distal end in like manner to the insertion instrument 14. The
insertion instrument 14' is introduced into the incision 54 in the
abdominal wall with the spreading body 102 in front. In order to
prevent the access device 10 on the holding section 98 from being
pushed back in the proximal direction, the operating surgeon holds
the feed element 94' in the position illustrated schematically in
FIG. 5 so that the second annular flange 46 of the access device 10
rests on the cone 104 on the one hand and the first annular flange
22 thereof rests against the stop surface 96 on the other.
Withdrawal of the insertion instrument 14 is simplified somewhat by
the feed element 94'. The operating surgeon holds the feed element
94' in position and pulls the holding section 98 out of the working
channel 18 in the proximal direction by grasping the handle element
88. The feed element 94' serves as a sort of hold-down member and
remains in position until the spreading body 102 impinges on the
feed element 94'. The retaining forces exerted by the abdominal
wall 56 on the access device 10 are then sufficient to pull the
spreading body 102 through the first annular flange 22.
[0090] In dependence on the length of the holding section 98, it is
also possible to hold two or more access devices 10 on the holding
section 98 one behind the other and to apply them successively in
the manner described with the aid of the insertion instrument 14'
as is illustrated schematically in FIG. 6. The feed element 94'
then forms a stop for the most proximal of the access devices 10
that have been pushed onto the holding section 98. This in turn
forms a stop for the next access device 10 that has been pushed on
at the distal side thereof.
[0091] In consequence, a first access device 10 can be applied into
an incision 54 in the abdominal wall 56 with the aid of the
insertion instrument 14'. The holding section 98 is withdrawn
relative to the feed element 94' until the spreading body 102 comes
to rest on the second annular flange 46 of the following access
device 10 that is held on the holding section 98. The one or more
access devices 10 remaining on the holding section 98 can then
either be applied as illustrated and described in principle in FIG.
6 or as schematically illustrated and described in FIG. 5. For a
simplified application of the access devices 10, the insertion
instrument 14' can be further optimised, for example, in the manner
of a "Multifire Applicator" in which the feed element can be moved
backwards and forwards in a desired manner with the aid of an
actuator element that is arranged on the handle element and coupled
to the feed element 94' so that an operating surgeon does not have
to hold the feed element 94' with his hand.
[0092] Both the access device 10 and the access device 70 may
optionally comprise a restraining device for preventing an access
device that has been inserted into the abdominal wall 56 from
moving in the proximal direction. A further exemplary embodiment of
an access device is illustrated in exemplary manner and provided
with the reference symbol 120 in FIG. 7. It differs, inter alia,
from the access device 10 in that the sleeve section 16 does not
comprise a second annular flange, but rather the working channel 18
extends up to the distal end 42 of the access device 120 along a
straight line.
[0093] Furthermore, the access device 120 comprises a restraining
device 122 incorporating at least one restraining member 124. Four
practically identical restraining members 124 are illustrated
exemplarily in FIG. 7. They are each formed by a projection 126
which projects away from the longitudinal axis 24 of the sleeve
section 16 in the radial direction and comprises a restraining
surface 128 facing in the proximal direction. Furthermore, each
projection 126 comprises a sliding surface 130 which faces away
from the longitudinal axis 24 and is inclined in the distal
direction. The projection 126 may extend only over a part of the
periphery of the sleeve section 16, optionally, it extends over the
entire periphery of the sleeve section 16 and is consequently in
the form of an annular projection. The restraining surfaces 128 and
sliding surfaces 130 described above create a kind of saw tooth
profile in the sectional view in FIG. 7, one could also say that an
outer contour of the access device 120 is undercut in the form of a
Christmas tree. The sliding surfaces 130 can extend transversely
with respect to the longitudinal axis 24, but they could be
inclined relative thereto, namely, in such a manner that an
undercut is preferably defined between the restraining surface 128
and an outer surface 132 of the sleeve section.
[0094] If the access device 120 is inserted into the incision 54
with the aid of one of the insertion instruments 14 or 14', the
restraining members 124 lead to it becoming hooked into the body
tissue when the sleeve section 16 is pulled in the proximal
direction. Inadvertent pulling of the access device 120 out of the
incision 54 can be prevented or at least the risk thereof is
diminished in this way. As was the case for the access devices 10
and 70, slippage of the access device 120 through the abdominal
wall 56 is prevented by the first annular flange 22.
[0095] A further exemplary embodiment of a surgical access device
is illustrated schematically in FIGS. 8A to 8C and is designated as
a whole by the reference symbol 120' therein. It differs from the
access device 120 merely by the design of the restraining device
122'. This comprises two substantially plate like restraining
members 124' which form a part of the wall 60 of the sleeve section
16. They are mounted in moveable manner on the sleeve section 16,
namely, they are pivotal about a pivotal axis 134 which is oriented
transversely with respect to the longitudinal axis 24. The pivotal
axis 134 runs substantially through the centre of gravity of the
restraining members 124'. The latter adopt the introduction
position in FIGS. 8A and 8B, i.e. they form a part of the wall 60
of the sleeve section 16.
[0096] If the proximal end of the restraining member 124' is swung
outwardly as is exemplarily illustrated in FIG. 8C, the restraining
member 124' adopts the restraining position. A rear end face of the
restraining members 124' facing in the proximal direction thus
forms a restraining surface 128'. This may, in particular, include
an angle of between 0.degree. and 90.degree. with the longitudinal
axis 24 in dependence on the pivotal angle. An inner surface 136 of
the restraining member 124' can likewise form a restraining
surface, namely, in the case where the restraining member 124' is
swung through approximately 90.degree. so that the inner surface
136 outside the sleeve section 16 bites into the body tissue and a
movement of the access device 120' in the proximal direction is
prevented or at least made more difficult.
[0097] The insertion instruments 14 or 14' can be used for the
purposes of applying the access device 120'. Optionally, it is also
conceivable in essence to dispense with the cone 104 in the
insertion instruments 14 and 14' so that only the tapered-pin 106
having a rounded-off peak 110 pointing in the distal direction
remains. For the application of the access device 120', the holding
section 98 is pushed into the working channel 18 in the way that
has already been described. The holding section 98 thereby blocks
any movement of the restraining members 124. These thus form a part
of the wall 60 as they substantially fill-up completely a
window-like through-opening 138 that is formed therein. When the
insertion instrument is withdrawn, the restraining members 124' can
be swung about the pivotal axis 134 in the previously described
manner so that the access device 120' is secured in the body tissue
in the desired manner.
[0098] A further exemplary embodiment of an access device
designated as a whole by the reference symbol 120'' is illustrated
schematically in FIG. 9. The construction thereof is similar to
that of the access device 120' and differs therefrom only in regard
to the size and position of the restraining members 124''. The
restraining members 124'' are arranged diametrically opposite each
other taken with respect to the longitudinal axis 24 and they are
disposed in an indentation 140 which, outgoing from the end 42,
extends in the proximal direction over approximately 40% of the
overall length 52 of the sleeve section 16. They are each mounted
such as to be pivotal about a pivotal axis 134 which runs
transversely with respect to the longitudinal axis 24 but does not
however intersect it. In addition, the pivotal axis 134 does not
run through the centre of gravity of the restraining members 124''.
The centre of gravity is located somewhat on the proximal-side of
the pivotal axis 134 so that the surrounding body tissue presses
the lever section 142, which extends in the proximal direction
starting from the pivotal axis 134, in the direction of the
longitudinal axis 24 and a lever section 144 of the restraining
members 124'', which extends in the distal direction starting from
the pivotal axis 134, can swing laterally outwards. In the
swung-out position thereof which corresponds to the restraining
position of the access device 120', the swung-out lever sections
144 take on the function of the second annular flange 46 in the
access device 10. The only difference is that the lever sections
144 are merely swung out on a temporary basis and do not extend
over the entire periphery of the sleeve section 16.
[0099] For the purposes of inserting the access device 120'', the
same insertion instrument can be used as was employed for the
insertion of the access device 120'. In the case of the access
device 120'' too, the restraining members 124 are forced into the
introduction position when the holding section 98 passes through
the working channel 18. When the insertion instrument is removed
from the access device 120'', the body tissue forces the
restraining members 124'' into the restraining position described
above which is illustrated schematically in exemplary fashion in
FIG. 9. Restraining surfaces 128'' of the lever sections 144 facing
at least partly in the proximal direction then form a stop which
acts in the proximal direction.
[0100] The access devices 120' and 120'' are preferably formed from
an inelastic synthetic material and thereby exhibit increased
stability. This is expedient, since the pivotal restraining members
124' and 124'' can then swing-out in a defined manner and anchor
themselves in the body tissue.
[0101] The access device 10, 70 and 120 can, in particular, be made
of an at least partially resilient material. The first annular
flange 22 and the second annular flange 46 can be formed in one
piece manner with the sleeve section 16 or be formed thereon by
means of a moulding process for example. It is conceivable in
particular for the restraining device 122 of the access device 120
to be formed in one piece manner with the sleeve section 16 or,
should another material be used therefor, by forming it thereon by
means of a moulding process. In order to optimise the process of
hooking into body tissue, the restraining members 124 can be formed
from a synthetic material which is less resilient than the sleeve
section 16 for example.
[0102] Optionally, all of the access devices described above can be
provided with a friction-reducing coating, namely, on both the
inner surfaces 32 and on the outer surfaces of the sleeve section.
Consequently, both the process of introducing the access devices
into the body and also the introduction of instruments into the
working channel can be facilitated thereby.
* * * * *